NCT05063565

TheraSphere With Durvalumab and Tremelimumab for HCC

An Open-Label, Prospective, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of TheraSphere™ Followed by Durvalumab (Imfinzi®) With Tremelimumab (Imjudo®) for Hepatocellular Carcinoma (HCC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.

Detailed description

A global open-label, prospective, multi-center Phase II trial designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients who are not a candidate for resection, thermal ablation or liver transplant at the time of study entry.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	TheraSphere Y-90 glass microsphere therapy	TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
DRUG	Durvalumab (Imfinzi) immunotherapy	1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met: * Absence of clinical symptoms or signs indicating clinically significant disease progression * No decline in performance status * Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention * No other treatment discontinuation criteria are met
DRUG	Tremelimumab immunotherapy	300 mg, single administration

Timeline

• Start date: 2023-11-03
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2021-10-01
• Last updated: 2026-03-27

Locations

36 sites across 5 countries: United States, France, Italy, Spain, Switzerland

Regulatory

• FDA-regulated drug study
• FDA-regulated device study